fda

29 06, 2024

FDA Continues to Highlight Data Integrity as a QC Lab Issue

FDA Continues to Highlight Data Integrity as a QC Lab Issue

2024-06-29T21:30:16+07:00June 29th, 2024|Categories: News|Tags: 21cfr, compliance builder, fda, laboratory informatics, Lims, lims configuration, matrix gemini, regulatory|

FDA warning letters continue to highlight the issue of ensuring data integrity within laboratories. How are you ensuring data is not changed (deliberately or otherwise) and is stored securely?

16 01, 2024

LIMS Ensures FDA 21 CFR Part 11 Compliance

LIMS Ensures FDA 21 CFR Part 11 Compliance

2024-01-16T21:49:39+07:00January 16th, 2024|Categories: News|Tags: 21cfr, fda, laboratory informatics, Lims, lims configuration, matrix gemini, regulatory|

LIMS helps laboratories comply to FDA 21 CFR Part 11 by enforcing signature policies for all electronic records. Ensuring electronic records and electronic signatures can be relied upon in the same way as paper records and handwritten signatures.

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